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expert reaction to news that approximately 450,000 women missed breast cancer screening invitations due to IT failure

About 450,000 women in England missed an invitation for routine breast cancer screening due to NHS errors.

 

Prof Peter Boyle FMedSci, Professor of Global Public Health at the University of Strathclyde, said:

“Breast cancer is the commonest form of cancer in English women although mortality rates have been falling rapidly for at least twenty years.

“It is a time for clear heads rather than scaremongering and that the public receives a common message from authorities rather than just another enactment of the blame-game.  This does not help those directly affected nor does it help public confidence.

“There is inadequate information available in the public domain at present to assess the impact of this error on premature mortality from breast cancer in the group of women effected. The Health Secretary is quoted as announcing that it was estimated that between 135 and 270 women may have had their life shortened. A UK National Daily headlined that 270 women have died.  Without more detailed information available, it is unclear what the public should believe. The current politicising of the situation is a great disservice to women.”

 

Prof Philippe Autier, Professor of Global Public Health at the University of Strathclyde, said:

“For ten years, publications in leading medical journals like the New England Journal of Medicine, the JAMA and the BMJ have shown that mammography screening has failed to reduce the burden of advanced-stage breast cancers in countries where this screening has been widespread for 20 to 30 years.  Decreases in breast cancer mortality observed in most high income countries after 1990 have not been faster and more pronounced in countries where screening was introduced at the end of the 1980s, compared with countries that introduced mammography screening fifteen to twenty years later.

“The Health Secretary, Jeremy Hunt, has announced a review. What is urgently needed is an independent review of the effectiveness of Breast Cancer Screening and of the effectiveness of Mammography: many lives depend on this.”

 

Prof Paul Pharoah, Professor of Cancer Epidemiology at the University of Cambridge, said:

“I believe that the furore over the NHS Breast Screening programme error has resulted in unnecessary worry for those women who may not have received a breast screening invitation.

“Breast cancer screening has both harms and benefits and so, if some people have not been invited for screening they will have avoided the harms as well as missing out on any benefits.  There has been no mention of this at all in the coverage to date.

“According to the Independent UK Panel on Breast Cancer Screening report published in 2012, for every breast cancer death prevented three breast cancers will have been ‘over-diagnosed’.  Over-diagnosed cancers are cancers diagnosed by screening that would never have been diagnosed in a woman’s lifetime if she had not had screening.   Detecting these very small early tumours might actually do more harm than good.  Some women with screen-diagnosed breast cancer will have unnecessary mastectomies, and some will have unnecessary radiotherapy.

“Actually estimating what those harms and benefits might be in numbers is extremely difficult and amounts to no much more than hand waving.  This is for two reasons.  We have little good evidence of the benefit of screening in older women; and there is no evidence at all of how much benefit/harm is associated with a single screen at the end of screening an individual for 20 years – in other words, the effect of missing this screen is unknown.

“We also need to remember that most breast cancers that are diagnosed can be very effectively treated.

“It has been reported that all women who were not sent an invitation will now be invited to have a catch up screen.  There is no evidence at all that this will serve any useful purpose.  Many of these women with be fit and well in their late 70’s.  The benefits and harms of further screening such women is completely unknown, but as women get older the risk of over diagnosis increases.”

 

Dr Amitava Banerjee, Senior Clinical Lecturer in Clinical Data Science at University College London, said:

“The idea of screening is that we diagnose or pick up disease early, before it has progressed, so that we can treat disease early, hopefully leading to better outcomes (i.e. less death and less suffering for patients). Breast cancer screening is one of several cancer screening programmes offered in the NHS and other countries, but is the largest population-wide programme for women. Women aged 50 to 70 are automatically invited for screening by mammography every three years.

The latest controversy uncovers three major issues. First, there was an IT error because a cut-off point of 70 was used rather than 71, which meant that for several years, an estimated 450 000 women were not offered a scan in the last three years of eligibility over the last decade, which is an avoidable error. Even as the Topol review1 of artificial intelligence in the NHS is underway, this episode does highlight that computer algorithms could be flawed, should be checked and would be better with human oversight.

Second, breast cancer screening, as it exists, is an imperfect tool for public health, but is only one part of the approach to preventing and treating breast cancer. Led by Professor Sir David Spiegelhalter, the NHS Breast Screening Leaflet2 summarises the best evidence. Of 200 women, 185 never have breast cancer, but 15 do develop breast cancer. Without screening, 8 out of 15 women would be treated and survive, 3 are unaffected and 4 women will die from breast cancer. If these 200 women were in the screening programme, 12 of the 15 who develop cancer are treated and survive, no women are unaffected, and 3 die from breast cancer. Therefore, breast cancer screening avoids only one death per 200 women screened (between the age of 50 and 70), but results in 3 more treatments. Put another way, at the population level, for a relatively small gain, there is a significant risk of over-diagnosis and over-treatment. The effectiveness of any screening programme is dependent on the accuracy of the test, the risk of the disease and whether early diagnosis influences treatment. No screening test is perfect, but it does seem that it is time to revisit whether mammography is the best test in its current form.

Third, as we already know, medical statistics are challenging for everybody, including health professionals, particularly when they concern uncertainty. Importantly, many politicians are not aware of the uncertainties of screening, and several inaccurate statements have been made and continue to be made without reference to the evidence regarding breast cancer screening. More importantly still, many women feel that the uncertainties of breast cancer screening have not been communicated to them. Therefore, there are gaps in public education and health literacy which need to be addressed urgently and prioritised if we are truly to enter an era of “patient-centred” and “personalised” medicine.”

1 https://hee.nhs.uk/our-work/topol-review

2 https://understandinguncertainty.org/visualisation-information-nhs-breast-cancer-screening-leaflet

 

Dr Nora Pashayan, Clinical Reader in Applied Health Research at University College London, said:

“If we look at women screened regularly with 100% uptake until age 70 vs age 67 and compare cumulative breast cancer incidence and breast cancer mortality up to age 85, we see an increase in diagnosis of breast cancer – but with no important decrease in breast cancer deaths.

“When presenting breast cancer deaths, we must look at the benefits and harms.  The benefits are reductions in breast cancer deaths following screening.  The harms are overdiagnosis – i.e. diagnosis of cancer that wouldn’t otherwise have been detected during the person’s lifetime, so would not have caused death – as well as false findings that lead to further, unnecessary investigation.

“Women may feel failed by the system. However, we need to keep the perspective and be clear on the messages.  Breast cancer screening prevents deaths from breast cancer in some women. On the other hand, not all cancers picked up by screening would result in death prevention; others won’t be picked up by screening at all.”

 

Prof Martyn Thomas FREng, Professor of IT at Gresham College and visiting professor of computer science at Manchester University, said:

“First TSB, then the breast screening IT system failure. How many more examples do we need before it becomes widely accepted that test-and-fix is an unscientific and often ineffective way to make important software systems fit for purpose.”

 

Dr Karla Evans, Assistant Professor in Psychology researching Medical Image Perception at the University of York, said:

“Breast cancer is the second leading cause of cancer deaths in women in the developed countries with 11,000 breast cancer deaths in the UK and 40,450 in the US, annually, representing around 7% and 12% of all cancer deaths, respectively. Screening mammography is the best available tool for early detection of cancer. It has made an important contribution to the 20-35% reduction in breast cancer mortality since the 1970s. An estimated 88% of women with early diagnosis of breast cancer will survive at least 10 years. However, the sensitivity and specificity of screening mammography are lower than what is desirable, with false negative rate of 20-30% and false positive rate of 10% reported in North America. There are practically no risks to women to do screening apart from a bit of discomfort, some radiation (which is negligible) when acquiring the images, and possible stress if the finding is a false positive.

“There are numerous reasons why cancers might be missed or false positive may occur and it is only a very small part due to human negligence. Using mammography, a non-invasive method of cancer detection has proven to be very effective and there is numerous research and initiatives in the UK, the US and Australia that is looking into further improving medical image perception from multiple sides. There are advances in imaging technology, improved training of medical experts, improved screening practices and computer aided detection technology. However, each country has different standards as to when women start to get regular screening and if they do and how often women are screened. These decisions are only partly based on scientific research and recommendations and are often dictated more by cost, logistics of implementation and feasibility. One of the biggest problems that plagues screening programs is also the falsehoods that are spread in the media questioning the benefits of screening programs. It makes the public find justifications for their own inertia to go for testing and unwillingness to face the hard realities that our bodies will not always function perfectly. This is similar to the problems the vaccination program and preventative dentistry has had in the past.”

 

Dr Michel Coleman, Professor of Epidemiology and Vital Statistics, and Head of the Cancer Survival Group, at the London School of Hygiene & Tropical Medicine, said:

“The report that 450,000 women aged 68-71 have not been invited to their last NHS breast screen since 2009, with potentially life-changing consequences for up to 270 women and their families, is a cause for serious concern. The fault is currently blamed on an IT failure, but the inquiry ordered by Health Secretary Jeremy Hunt will probably blame inefficiencies caused by pressure of work and lack of resources.

“It was reported recently that the Health Secretary had pleaded unsuccessfully with the Prime Minister to allow more doctors to enter the UK to meet the increasing needs of the NHS. A year ago, he said there was no excuse for the record numbers of people waiting more than two months to start cancer treatment after urgent referral. He was quoted as saying: ‘I am doing this job because I want NHS care to be the safest and best in the world’.

“Fine, but then it is surely time the Health Secretary told the Prime Minister to reverse the NHS funding squeeze imposed since 2010. What the government calls ‘efficiency savings’ are recognised by everyone else as drastic cuts. The solution is clear enough.”

 

Prof Sir Richard Peto FMedSci, Professor of Medical Statistics & Epidemiology and Co-Director of the Clinical Trial Service Unit at the University of Oxford, said:

“In most general practices, or groups of general practices, in England the NHS Breast Screening Program, monitored by Public Health England (PHE), seeks about every third year to offer X-ray screening examinations to all women registered with that practice who will be of age 50-70 by December 31. This approximately 3-year cycle has meant that the last routine breast screening invitation would usually be received at age 68, 69 or 70.

“The Secretary of State, Jeremy Hunt, made a statement in the Commons that in England since 2009 about 450,000 women did not get their final screening invitation at about age 70, that some 300,000 of them are still living here and registered with a GP, and that these women will all be written to this month. Many of those who are still of age 71 or 72 will also receive an additional breast screening invitation during 2018. (NB It has always been the case that women over 70 can be referred by themselves or their GP for screening.)

“There is still uncertainty about the benefits and harms of additional screening after the age of 70, and although the randomised AgeX trial (www.agex.uk) is currently addressing this, it is not expected to yield medically reliable results until about the mid-2020s.

“The additional invitations to be sent out following the Secretary of State’s announcement are all for women who were not, when last considered for routine screening, quite old enough to be eligible for the AgeX trial. Hence, today’s announcement does not directly affect women already in the trial, the current trial information sheet, or the current trial protocol.

“If, however, PHE eventually adjusts some aspects of the computerised rules about the exact timing of the last routine invitation for screening, then once the details of these changes have been decided matching adjustments to the AgeX protocol will be needed to avoid overlap.”

 

Prof Malcolm Sperrin, Fellow of the Institute of Physics and Engineering in Medicine, said:

“Screening is a strategic technique that balances the risk from an imaging or other intervention with a net positive outcome.  Whilst X-rays can be associated with a risk of cancer genesis, the chances of it picking up an otherwise asymptomatic cancer are greater.  Cancers at this early stage are more treatable and hence there is a net benefit to the population.  The subtle risk is that cancers could be caused in women who would otherwise not have developed any disease and hence it is vital to see the screening programme as a population benefit.  Clearly when cancers are found, the benefit is to the individual.  Other screening programmes do exist such as ultrasound, aortic aneurism, and the obvious ones such as cholesterol testing.  Breast screening is particularly emotive because of the use of ionising radiation.

“The risk to older women is complex because although in theory the X-rays do present a risk, the actual effect such as cancer genesis has a time scale greater than the population expected life span for that age.  Screening can still be useful for high-risk patients or for monitoring progress but these are not generally considered to be part of the rationale for the screening programme.  Advice is always to speak to the experts in the form of GP or other specialist.

“The net benefit is always being reviewed based upon factors such as radiation exposure, image quality and life expectancy.  This is extremely complex since one argument is that as life expectancy increases, then so should the upper screening age group, but if cancers preferentially occur at younger ages, then there is no net benefit.  The familiar self-inspection is key and this has been extended to male testicular screening.”

 

Baroness Delyth Morgan, Chief Executive, Breast Cancer Now, said:

“We are deeply saddened and extremely concerned to hear that so many women have been let down by such a colossal systematic failure. That hundreds of thousands of women have not received the screening invitations they’ve been relying upon, at a time when they may be most at risk of breast cancer, is totally unacceptable.

“We know this will unfortunately be incredibly difficult news for many women to hear. Public Health England will be directly contacting all women affected – we’d urge against panic and encourage anyone concerned that they have missed their screening invitations to contact the Public Health England helpline directly for further advice. Screening prevents deaths from breast cancer – the earlier the disease is detected, the more likely treatment is to be successful and we’d encourage all women to attend their appointments.

“For those women who will have gone on to develop breast cancers that could have been picked up earlier through screening, this is a devastating error.

“It is right that Public Health England are offering the option of catch-up screening for those affected, and hope that women will choose to take this up. With the diagnostic workforce already at crisis capacity, significant investment – including the recruitment of over 200 mammographers and at least 50 radiologists – is now needed to ensure the Screening Programme can continue to run effectively.

“It is beyond belief that this major mistake has been sustained for almost a decade and we need to know why this has been allowed to happen. We welcome the Independent Inquiry to ensure this can never be repeated.”

 

Declared interests

None received.

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